Cardiorenal Syndrome Clinical Trial
Official title:
Accuracy of Urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) in Predicting Cardio-renal Syndrome in Acute Decompensated Heart Failure at Emergency - CYNDERELA-HF Study
Rationale: Heart Failure (HF) elevated prevalence in Brasil and the world; 20-30% AHF
patients develop CardioRenal Syndrome (CRS) type 1; Worsening Renal Failure (WRF) is a
prognostic marker of mortality in Acute HF;NGAL is a novel biomarker of Acute Kidney Injury
released in 2 hours, and addressed in several different clinical scenarios(contrast injury,
cardiopulmonary bypass, critical illness.
Hypothesis: Admission NGAL predicts CRS in AHF patients admitted to the Emergency Room (ER).
Primary goal: To evaluate the diagnostic accuracy and the best cutoff value of urinary NGAL
to predict the development of CRS type 1 in patients admitted to the Emergency Room.
Secondary goals: 1- To evaluate the prognostic impact of NGAL on in-hospital adverse outcomes
(length of hospitalization, death, institution of renal replacement therapy, use of
vasoactive drugs, mechanical ventilation).2- Evaluate the prognostic impact of NGAL in
adverse outcomes in 30 days, 60 days and 6 months (death, rehospitalization, institution of
renal replacement therapy).3- Identify clinical and hemodynamic characteristics of Acute HF
that can influence the evolutionary behavior of NGAL levels in 48 hours.4- Identify the
association of drugs commonly used for HF management, which might influence the evolutionary
behavior of NGAL levels in 48 hours.5-Assess the impact of NGAL results in clinical decision
making.
Methods: Observational, prospective, blinded study. Population: Acute HF patients admitted to
the ER of Hospital Pró Cardiaco and Hospital Antonio Pedro - Universidade Federal Fluminense.
Statistics: Convenience Sample size (n=180); determination of best cut-off: ROC analysis;
Predictive performance of the cut-off: sensibility, specificity, likelihood ratio, predictive
value, accuracy; Identification of variables to predict CRS: logistic regression and
square-Qui test; Correlations analysis of normally distributed variables: Pearson's linear
correlation test; Mean values for normally distributed variables: Mann-Wittney test;
Significance on p<0,05; Intra-assay variation analysis.
Study chronogram: Recruitment: 12 months; Results analysis and conclusions: 60 days;
Manuscript preparation for paper submission: 30 days.
Rationale: Heart Failure (HF) elevated prevalence in Brasil and the world; 20-30% AHF
patients develop CardioRenal Syndrome (CRS) type 1; Worsening Renal Failure (WRF) is a
prognostic marker of mortality in Acute HF; available biomarker shows irreversible damage,
late in CRS evolution.(creatinine);NGAL is a novel biomarker of Acute Kidney Injury released
in 2 hours, and addressed in several different clinical scenarios(contrast injury,
cardiopulmonary bypass, critical illness...); Acute HF patient's risk stratification will
allow appropriate resource allocation and establishment of criteria for hospital admission
and discharge.
Hypothesis: Admission NGAL predicts CRS in AHF patients admitted to the Emergency Room (ER).
Primary goal: To evaluate the diagnostic accuracy and the best cutoff value of urinary NGAL
to predict the development of CRS type 1 in patients admitted to the Emergency Room.
Secondary goals: 1- To evaluate the prognostic impact of NGAL on in-hospital adverse outcomes
(length of hospitalization, death, institution of renal replacement therapy, use of
vasoactive drugs, mechanical ventilation).2- Evaluate the prognostic impact of NGAL in
adverse outcomes in 30 days, 60 days and 6 months (death, rehospitalization, institution of
renal replacement therapy).3- Identify clinical and hemodynamic characteristics of Acute HF
that can influence the evolutionary behavior of NGAL levels in 48 hours.4- Identify the
association of drugs commonly used for HF management, which might influence the evolutionary
behavior of NGAL levels in 48 hours.5-Assess the impact of NGAL results in clinical decision
making.
Methods: Observational, prospective, blinded study. Population: Acute HF patients admitted to
the ER of Hospital Pró Cardiaco and Hospital Antonio Pedro - Universidade Federal Fluminense.
Statistics: Convenience Sample size (n=180); determination of best cut-off: ROC analysis;
Predictive performance of the cut-off: sensibility, specificity, likelihood ratio, predictive
value, accuracy; Identification of variables to predict CRS: logistic regression and
square-Qui test; Correlations analysis of normally distributed variables: Pearson's linear
correlation test; Mean values for normally distributed variables: Mann-Wittney test;
Significance on p<0,05; Intra-assay variation analysis.
Study chronogram: Recruitment: 12 months; Results analysis and conclusions: 60 days;
Manuscript preparation for paper submission: 30 days.
;
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